Cleared Traditional

K934253 - EXACTECH ALL POLY ACETABULAR CUP

K934253 is an FDA 510(k) clearance for EXACTECH ALL POLY ACETABULAR CUP, manufactured by Exactech, Inc.. The device is a Class 1 Orthopedic device with product code JDZ cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K934253 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
241d
Days
Class 1
Risk

K934253 is an FDA 510(k) clearance for the EXACTECH ALL POLY ACETABULAR CUP. Classified as Mixer, Cement, For Clinical Use (product code JDZ), Class I - General Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on April 29, 1994 after a review of 241 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4210 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Exactech, Inc. devices

FDA 510(k) Submission Details - K934253

510(k) Number K934253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date April 29, 1994
Days to Decision 241 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 122d · This submission: 241d
Pathway characteristics
Predicate-based equivalence.

JDZ Device Classification - Class 1, General Controls

Product Code JDZ Mixer, Cement, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4210
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JDZ Mixer, Cement, For Clinical Use

All 11
Devices cleared under the same product code (JDZ) and FDA review panel - the closest regulatory comparables to K934253.
PRISM BONE CEMENT MIXING SYSTEM
K925025 · Depuy, Inc. · Jan 1994
STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST
K912190 · Stryker Corp. · Aug 1991
REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS
K892937 · Dentsply Intl. · Jun 1989
ZIMMER VACUUM MIXING SYSTEM
K861086 · Zimmer, Inc. · Apr 1986
MIX EVAC II
K854077 · Stryker Corp. · Jan 1986
SIMPLEX ENHANCEMENT MIXER
K853310 · Howmedica Corp. · Sep 1985